Any business organization that is involved in creating, receiving, transmitting and maintaining Protected Health Information (PHI) has to comply with the requirements set out in Health Insurance Portability and Accountability Act (HIPAA). Such businesses, called Business Associates, since they carry out these functions on behalf of what are called Covered Entities; are legally obliged to show compliance with the provisions of HIPAA, whose main aim is to protect the privacy and confidentiality of patient information.

So, any Business Associate has to know how to comply with the provisions of HIPAA. Considering that the provisions of HIPAA have undergone major changes from the time of its enactment in 1996 up until 2013; Business Associates often find that showing compliance with the provisions of this legislation is complex. But failing to do so attracts hefty fines and penalties.

Understanding HIPAA provisions is the key to implementation

Although HIPAA implementation appears somewhat intimidating at first glance, in reality, it is not so. It can be implemented with ease and felicity in a manner that meets all the regulatory requirements. How? By breaking down the requirements into separate parts. The ways of taking this very sensible and commonsensical approach to HIPAA implementation by Business Associates and their Covered Entities, will be the subject of a very useful two-day seminar that is being organized by GlobalCompliancePanel, a highly reputed provider of professional trainings in the areas of regulatory compliance.

He will, for instance, highlight the role of the social media and how to use the electronic media for staying updated and thus reducing the crucial element of time. He will also highlight the importance of managing risks in HIPAA compliance. This is all the more critical, considering that the Office of Civil Rights (OCR) has found that a shockingly high 94% of Covered Entities failed the Risk Management audit and about 87% failed the Risk Analysis audit. This was despite the fact that every Covered Entity knew well in advance of the upcoming audit, and had filled up a pre-audit questionnaire, which gave them a clear idea of what was to come in terms of the questions that HIPAA inspectors would be asking them, and what documentation were needed from them.

The central aim of this learning session is to help participants understand how Business Associates and Covered Entities can take simple and easy steps to stay compliant, so that they don’t have problems in meeting HIPAA requirements for compliance.

Learning at this highly valuable Areas:

Thorough Understanding of HIPAA Rules

What they are

How they work together

Why and How they were made

How they are changing and what to expect next

HIPAA Risk Analysis – Risk Management for Your Organization

A Practical Guided Exercise done in class on your computer to take home

Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone. we never expected to actually to connect with other people in the blogging community.

we are so incredibly thankful for each and every one of you who follows and comments on my blog posts. Please know that!

The beginnings of all that the USFDA regulates can be traced right to the early decades of the founding of the nation. In a sense, the FDA, even if came to be called by that formal name much later; embodies the discipline and value set that the new created nation sought to represent. Regulation of all aspects of American life was deeply ingrained very early in the nation’s history, and the FDA was one of prime institutions that played a part in making this happen.

How has the FDA evolved and shaped up over the years? What are the important milestones of this history? This makes interesting reading, because the USFDA has had the kind of history whose colorfulness is matched by few other regulatory agencies around the world.

An indication of the extent to which the FDA attaches importance to ensuring the wellbeing of the American people can be gauged from the fact that the food and other products that this agency regulates account for a fifth of the total money that the nation’s consumers spend. Just its budget – well over four billion in 2014 – is a good indicator to the way in which the FDA has spread its influence in the various spheres of American life. It regulates almost all food items with the exception of meat and poultry.

This situation has not been reached accidentally or overnight. The FDA has by and large kept pace with the developments in the areas it regulates. This was largely true till the advent of very recent technology-led areas such as biotechnology and the social media, where too, the FDA has been trying to put its best foot forward.

The start of formal regulation A look at the history of the FDA points to the year 1848 as the start of the first formal aspects of regulatory history. That was the year in which Lewis Caleb Beck took his appointment with the Patent Office. His mandate was to chemically analyze agricultural products. This is considered as the first task that was aimed at regulating a product that people consumed. This function rolled over to the Department of Agriculture, which was created in 1862.

The Act of 1906The next step in solidifying the regulatory aspects of life in the US was taken in 1906, with the promulgation of the Pure Food and Drugs Act in 1906. Stretching to some two decades of wrangling between the American Congress and the food industry to formulate, the Act of 1906 sought to prohibit adulterated and misbranded food and drugs from interstate commerce.

The 1938 Food, Drug, and Cosmetic ActThe next major milestone in the aspects of regulatory history in the US took place in 1938. The 1938 Food, Drug, and Cosmetic Act prescribed and detailed the legal requirements for products the FDA – which this Act created – regulated. In this Act, one can trace the earliest tidings of a major activity that the FDA has been carrying out since then: Prescribing the requirements for ensuring quality by prohibiting false claims by manufacturers and advertisers.

Over time, the 1938 Act expanded to include more areas such as cosmetics, devices and veterinary medicines, thus strengthening the foundation for regulation and making it more expansive. Since the passage of the 1938 Food, Drug, and Cosmetic Act; two major events happened on the regulatory scene. The outbreak of tetanus and diphtheria diseases in the 1960’s compelled the FDA to take a more proactive approach to vaccinations.

Another major, earthshaking event was the tragedy that thalidomide unleashed on Europe in the 1960’s, which stunted the growth of hundreds of children, which was mainly due to regulatory lapse. This did not happen in the US, mainly because of the efforts and diligence shown by Frances Kelsey, in her role as FDA reviewer. Frances plainly refused to approve thalidomide because she was not convinced about its safety, an act which made her a cult figure in FDA and American and Canadian medicinal history till her death in 2015.

Aspects of regulatory history in the US in the 1990’sFollowing the 1960’s, the next major milestone in the aspects of regulatory history in the US happened in 1990, when the Nutrition Labeling and Education Act was passed. This law was important because it changed the American perspective of labeling of products in the food and pharmaceutical industries. The Nutrition Labeling and Education Act requires manufacturers to provide nutritional information about products on their labels, with the caveat that false labeling information will lead to consequences.

Good Documentation Practices are the soul of many regulated industries. The FDA, like all other regulatory agencies, makes GDP a central element of its regulations, and bases it on the principle of evidence. For the FDA and other regulatory agencies across the world, what is not documented is nonexistent.

Good Documentation Practices are essential for a number of disciplines. The soul of documentation is, naturally, the written word. What happens when something that happened is not actually written down? It is a work of no practical use, because apart from those that carried out the particular undocumented task; no one else is aware of it. And even when the people who did that task or were witness to it are prone to have their own interpretation and perception of what was done. This is why proof in the form of writing is the most important element of Good Documentation Practices.

What to write, and how toGDP should not only be about just writing down; it is about what to write and also, how, meaning, in what manner. If there has been an intervention in any method of manufacture or any other activity in the regulated industries; the change should be noted down in the proper format as prescribed by the FDA. This enables everyone concerned, from the people in the organization to the auditors to the regulatory agencies, to clearly identify what action was carried out, by whom and when. This further leads to a discovery of the impact of the actions. This is the key to determining the effectiveness of the application of the GDP principles in the particular case.

This is why the FDA has very clear-cut requirements and expectations of GDP from the industries it regulates. These clearly explain the method by which to document the said document, the ways of doing it, and what actions to take when the need arises.

Quality Assurance is unthinkable without the application of GDP principles. The main reason for establishing GDP is ensure that the documentation does the following to the record in question:

What needs to be documented?Another major element of GDP is to determine what is to be documented. The FDA and other regulatory agencies require the principles of Good Documentation Practices to be applied across a number of activities at different stages. These include:

The EMA’s requirementsThe EMA also has clear-cut guidelines on Good Documentation Practices. Some of its core requirements relate to

Specifications

All aspects of the manufacturing including the product’s formulae, the way in which the processing was done, the methods of its packaging, and the extent to which its testing instructions are written down

SOPs

Protocols

Technical agreements

Further, most regulatory agencies have their own requirements with regard to the styling, ways by which the amendments, if any, need to be jotted down, the type of ink to be used, the way in which the review, if any, needs to be entered, and who should put signatures and where, so on. Manufacturers who fall under the purview of respective regulatory agencies need to adhere to these.

And, for other reasons, as wellImplementing Good Documentation Practices is a great idea to have for meeting regulatory requirements, because companies that do not meet these requirements are in a spot of bother about a number of issues. However, in addition to this, there is also the need for maintaining GDP for business reasons, as well. A business that complies with the requirements set out by the FDA or other regulatory agencies in relation to Good laboratory practices, the CFR regulations such as 21 CFR Parts that apply to various industries, and also as required as part of national and global agencies; earns a good name in the market and is considered a reliable company.

The organisation is working in collaboration with Digital Health and innovation and crowdsourcing agency Clever Together on the online workshop, which forms part of the Building a Digital Ready Workforce programme.

It will be launched on 22 November in partnership with BCS Health and Care, the Federation of Informatics Professionals in Health and Social Care, and the Faculty of Clinical Informatics.

James Freed, chief information officer at Health Education England, told Digital Health the exercise was a chance to gather the views of those who already have a strong voice as well as those who are less commonly heard.

“In almost all technological programmes I have seen, our efforts are mostly about technology and very little about process, and the process redesign, and almost none on people,” he explained. He hopes the new online workshop will address that.

Andy Kinnear, chair of BCS Health and Care, added the aim was to hear from “digital experts; the wider group of people involved in the digital space such as nurses, doctors and care professionals; and the entire health and social care workforce”.

The online workshop will run for about three weeks and its results will form the basis for how the BRDW programme will prioritise and invest £6m over the next four years. Its findings will be extensively covered by Digital Health.

This article covers policy needs concerning the rapidly evolving field of microbiome and diets with respect to health and disease. It captures some key outcomes of a multi-stakeholder dialogue (Brussels, May 2016), spearheaded by a joint effort of the Organisation for Economic Co-operation and Development (OECD) and the Department of Economy, Science and Innovation of the Flemish Government (Belgium), to help design and/or interpret regulatory frameworks for food and drugs to support innovation to benefit society, while guaranteeing safety and efficacy of products and ensuring the science base.

Introduction

The combined genomes of the microbial ecosystems that live in symbiosis or as commensals with the human body can be defined as the human microbiome. These microbial ecosystems not only include bacteria and archaea, but also fungi, protozoa, and viruses. Different microbial ecosystems colonise the mouth, the skin, the vaginal and intestinal tract, of which the latter has the highest biodiversity, composed of more than 1000 phylospecies.

An Interface Between Human Genetics and Diet: the Gut Microbiome

The human gut microbiota has been described as a key biological interface between human genetics and environmental conditions, such as diet, that can modify the composition and the functioning of the intestinal microbiome. In that sense, it may be considered a virtual organ which is an integral and essential part of the body.1 Through nutritional intervention, the gut microbiome may be altered to generate better wellbeing and protection against many diseases or even to cure certain conditions.2-4

The gut microbiome can be linked to many Non-Communicable Diseases (NCDs), such as cardiovascular diseases, cancer, diabetes, and metabolic syndrome related to increasing incidence of obesity. More recently, also neurological diseases have been related to gut microbiota and diet and are considered as NCDs.5, 6 The burden of ageing related dementia and other NCDs is exponentially increasing in relation to changing life styles and ageing of the population, conditions that are associated with gut microbiome alterations. Changing demographics worldwide, combined with the broader adoption of the western diet and lifestyle increases the burden of NCDs, creating serious challenges for the public healthcare systems. Prevention and more efficient treatment of NCDs not only offer important economic advantages for healthcare systems, it also contributes to the reduction of poverty as only healthy people can actively participate to society and economies.7-9 Recent scientific studies are linking dietary habits to an array of health conditions in new ways and indicate that nutrition has a determining influence that start even before birth and can influence the development of complex pathologies.10, 11

Opportunities and Hype

New insights about the importance of the intestinal microbiome and the modulating effect of diet are opening new possible ways of treatment and prevention that may contribute to the sustainability of healthcare systems by keeping the increasing healthcare costs under control. Innovations based on better understanding of how the intestinal microbiome functions and regulates our health and how it is impacted by what we eat are expected also to lead to preventative medicine and contributions to longer wellbeing in general.

However, the field is subject to some hype. Although insights are growing fast, at this moment it is still unclear how health or disease is determined by the human microbiomes. In most cases, a certain microbiome composition can at best be associated with certain condition. The causal relation of nutrition, gut microbiome composition and health is not clearly understood yet, such as whether a healthy microbiome can be defined at population level, what determines its resilience when disturbed, or how its composition can be beneficially manipulated. Such primary knowledge is required before therapies targeting the microbiome can be developed.

Nevertheless, there is a clear interest of food and pharmaceutical developers and industries to develop new products that target the gut microbiome, for better well-being or to manage chronic disease conditions. Moreover, microbiomes are also a source of novel bioactive compounds that may be used for innovative applications.

Identifying Policy Needs

To follow the pace of new scientific insights and translate these to innovative applications, there is a need to accelerate policy actions at the national and international level, to address scientific and regulatory challenges as well as to ensure safety and efficacy and efficient take up by consumers and healthcare professionals.12-14

To stimulate innovation based on the new insights of how the human microbiome and the gut microbiome in particular is functioning, in May 2016, the department of Economy, Science and Innovation of the Flemish Government in Belgium organized a workshop on ‘The Microbiome, Diet and Health: Assessing Gaps in Science and Innovation’ in Brussels in collaboration with OECD and the Business and Industry Advisory Committee (BIAC), the industry association linked to OECD.15

This workshop brought together scientists from academia and industry, experts in regulatory issues and policy makers to identify and discuss on policy needs for this field to progress and deliver upon the promises. The regulatory frameworks in place need to follow fast the new developments and combine a right balance between measures to ensure safety and consumer/patient protection and flexibility to adapt to these new developments.16-18

This article summarizes some of the policy needs that were identified as well as messages from workshop participants, how to address these and help move from hype to solid intervention or prevention. A complete workshop report is published by OECD.

On October 26, first-time father Antwon Lee took his two-month-old son Debias King to get his first vaccinations. Lee, 29, said he was very nervous for the appointment, telling People Magazine that he “felt kind of scared a little bit,” as he knew the child was “going to go through some pain.” Before the visit, he also continually reassured his son that he could cry if he needed to.

When it came time for the vaccinations, Lee held his son in his arms and told the little boy to “stay strong,” while Shamekia Harris, Lee’s girlfriend, recorded the visit on her phone. Little Debias did cry as the nurse gave him his shots, but stopped soon afterward when Lee consoled him.

The video has since gone viral, with about 13 million views, 51 thousand likes, and 186 thousand shares as of Wednesday.

Sadly, Lee’s father, Anthony Lee, 57, died that same day due to complications from drinking. Lee explained to People that he was emotional and very close to his father, and that he later spoke to his son Debias about his hopes for the future.

“I talked to him like a grown up … I told him, before I leave, want to see him succeed,” Lee said.

Lee wishes that the video will remind others of the importance of fatherhood, “I want them to take care of their kids, because when you sign up for something, you have to stick with it,” he told People.

Lee, however, isn’t the only person to go viral for his vaccination video: In 2014, pediatrician Michael Darden gained attention for his unique approach to giving shots, and the video still doesn’t disappoint: